Spectrophotometric methods for quantitative estimation of sertraline hydrochloride from tablet formulation

1. Ravindra N, et al / Int. J. of Pharmacy and Analytical Research Vol-3(4) 2014 [422-425]
www.ijpar.com
~ 422~
IJPAR |Vol.3 | Issue 4 | Oct-Dec-2014
Journal Home page: www.ijpar.com
Research article Open Access
Spectrophotometric methods for quantitative estimation of
sertraline hydrochloride from tablet formulation
Ravindra N*1
1
Department of Pharmaceutical Analysis, Chilkur Balaji College of Pharmacy, Aziz nagar post,
Moinabad road, Hyderabad- 500075, India.
* Corresponding author: Ravindra N
E-mail id: nravi1965@gmail.com
.
ABSTRACT
Two simple and sensitive visible spectrophotometric methods have been developed for the quantitative estimation of
Sertraline Hydrochloride from its tablet formulation. The developed methods are based on formation of chloroform
extractable colored complex of drug with alizarin red and tropaeolin ooo. The chloroform extracted complex of drug
with alizarin red showed absorbance maxima at 425.0 nm and linearity was observed in the concentration range of 20-
90 µg/ml (method-I), with tropaeolin ooo showed absorbance maxima at 485.0 nm and linearity was observed in the
concentration range of 3-24 µg/ml (method-II). Results of analysis for both the developed methods were validated
statistically and by recovery studies.
Keywords: Sertraline Hydrochloride, Chloroform extract, Alizarin red, and Tropaeolin.
INTRODUCTION
Sertraline1
chemically is (1S,4S)-4-(3,4-Di-chloro
phenyl)-1,2,3,4-tetrahydro-N-methyl-1-1-
naphthalenamine. It is used for treating depression and
comes under second generation antidepressant drugs in
the class of selective serotonin reuptake inhibitor
(SSRI)2
. Literature survey reveals that few analytical
methods for estimation of Sertraline Hydrochloride
from pharmaceutical dosage forms by using LC-MS3
,
RP-HPLC4
and UV-Visible Spectrophotometre5
have
been reported. However, there is no work in the
literature reported about the visible
Spectrophotometric estimation of Sertraline
Hydrochloride in pharmaceutical dosage forms with
Alizarin red & Tropaeolin ooo reagents. An attempt has
been made in the present study to develop two simple
& rapid visible Spectrophotometric methods for
analysis of Sertraline Hydrochloride in pharmaceutical
dosage forms after referring various analytical
methods.6-8
EXPERIMENTAL
A Shimadzu UV/Visible spectrophotometer- 1700 with
1 cm matched quartz cells was used for spectral
measurement. All the chemicals used were of analytical
ISSN: 2320-2831

2. Ravindra N, et al / Int. J. of Pharmacy and Analytical Research Vol-3(4) 2014 [422-425]
www.ijpar.com
~ 423~
grade, alizarin red solution (0.1% w/v) and tropaeolin
ooo (0.03% w/v) was prepared in acid buffer9
pH 1.2
and pH 1.6 respectively and extracted several times
with chloroform so as to remove chloroform soluble
impurities. Buffer solutions were prepared in double
distilled water. The tablet samples of Sertraline
Hydrochloride were procured from the local market.
For method I, in a series of 10 ml volumetric flasks
aliquots of standard drug solution of Sertraline
Hydrochloride (100 g/ml) in chloroform were
transferred and diluted with the same so as to give
several dilutions in the concentration range of 20-90
g/ml of drug. To 10 ml of each dilution taken in a
separating funnel, 10 ml of alizarin red solution was
added, shaken and allowed to stand for 10 minutes for
the formation of colored complex. The colored
chloroform layer was separated out and absorbance was
measured at 425.0 nm against a reagent blank. A
calibration curve was prepared by plotting
concentration versus absorbance.
For method II, in a series of 10 ml volumetric flasks
aliquots of standard drug solution of Sertraline
Hydrochloride (30 g/ml) in chloroform were
transferred and diluted with the same so as to give
several dilutions in the concentration range of 3-24
g/ml of drug. To 10 ml of each dilution taken in a
separating funnel, 10 ml of tropaeolin ooo solution was
added, shaken and allowed to stand for 10 minutes for
the formation of colored complex. The colored
chloroform layer was separated out and absorbance was
measured at 485.0 nm against a reagent blank. A
calibration curve was prepared by plotting
concentration versus absorbance.
For analysis of formulation, twenty tablets of Sertraline
Hydrochloride were accurately weighed and average
weight per tablet was determined. The tablets were
powdered and powder equivalent to 100 mg of
Sertraline Hydrochloride was accurately weighed and
extracted four times with 20 ml portions of chloroform,
the combined extract was filtered through Whatmann
filter paper No.41 into 100 ml volumetric flask. The
residue was washed with chloroform and the washings
were added to the filtrate, final volume of filtrate was
made up to the mark with chloroform. From the above
filtrate 10 ml was further diluted to 100 ml in a
volumetric flask to get a tablet sample stock of 100
µg/ml.
For method I, 4 ml of above stock was further diluted
to 10 ml with chloroform and for method II, 1.5 ml of
above stock was further diluted to 10 ml with
chloroform. This was treated as per the respective
procedure for the calibration curve and absorbance was
measured at 425.0 and 485.0 nm respectively and the
amount of drug present in sample was computed from
respective calibration curve.
RESULTS AND DISCUSSION
Both the developed methods were repeated five times
for two different strength of tablet formulation. Results
of analysis are reported in Table 2.
Recovery studies were carried out for both the
developed methods by addition of known quantity of
pure drug solution to pre analyzed tablet sample
solution at three different concentration levels. The
result of recovery studies is reported in Table 2.
The proposed Spectrophotometric methods for
determination of Sertraline Hydrochloride from tablet
formulations are based on formation of chloroform
extractable colored complex of drug with alizarin red
and tropaeolin ooo. The pH required for method I and
II was optimized at pH 1.2 an pH 1.6 respectively . The
optical characteristics such as Beer’s law limits,
sandell’s sensitivity, molar extinction coefficient and
percent relative standard deviation, (calculated from the
eight measurements with in the Beer’s law limits) were
calculated and the results are summarized in Table-1.
Table-I Optical Characterstics And Precision Of Proposed Methods I And Ii
Parameter Method-I Method-II
λmax (nm) 4255 488
Beer’s law limits (μg/ml) 20-90 3-24
Molar absorptivity
(Lmole-1
cm-1
)
0.0545x106
0.1595x106

3. Ravindra N, et al / Int. J. of Pharmacy and Analytical Research Vol-3(4) 2014 [422-425]
www.ijpar.com
~ 424~
Sandell’s sensitivity
0.0063 0.00215(μg cm-2
/0.001 absorbance unit)
Regression equation (Y=a+bC)
Slope (b) 0.0161 0.0473
Intercept (a) -0.0027 -0.0052
Correlation co efficient (r) 0.9999 0.9999
Relative standard deviation (%)* 0.0722 0.1979
% Range of error (confidence limits)*
0.05 level 0.0604 0.1655
0.01 level 0.0894 0.2448
Y = a + b C, where C is concentration in μg/ml and Y is absorbance unit.
* Eight replicate samples
Table - II Assasy And Recovery of Sertraline Hydrochloride In Dosage Forms
Sample Labeled amount (mg/tab) Amount obtained (mg/tab) % Recovery**
Proposed method Reference*
method I II
I II
1 25 24.96 24.97 24.94 99.86 99.88
2 25 24.98 24.97 24.96 99.95 99,95
3 25 25.02 25.04 25.02 100.08 100.12
* Reference U.V. Method developed in our lab ** Average of three determination
Regression characteristics like standard deviation of
slope (Sb), standard deviation of intercept (Sa), standard
error of estimation (Sc), and percentage ranges of error
(0.05 and 0.01 confidence limits) were calculated and
are shown in Table-1.
Recovery studies were satisfactory which shows that
there is no interference of excipients. The developed
methods were found to be simple, rapid and accurate
and can be used for routine analysis of drug from tablet
formulations.
ACKNOWLEDGMENTS
The author is thankful to Ajanta Pharma, Mumbai for
providing the gift samples of Sertraline Hydrochloride.
The author is also thankful to the management of
Chilkur Balaji college of Pharmacy, Hyderabad, for
providing the additional laboratory facilities.
REFERENCES
[1] Budvari S, 2001,The Merck Index,13th Edn., Merck and Co., Inc., White house Station, NJ, p. 1519
[2] Tripathi K.D; essentials of Medical Pharmacology: Jaypee Publishers(P) Ltd, New Delhi, 5th
Ed., 2003, 48-52.
[3] Jain d.S., Sanyal M., Subbaiah G., Pande U.C., and Shrivastav P.,J. Chromatogr B Anal. Tech. Biomed. Life
Sci, 2005,829(1-2), 69-74.
[4] Patel, J., Spencer, E.P. and Flanagan, R.J., Biomed. Chromatogr., 1996,10(6),351, Anal. Abstr., 1997,59(2),
2G44.
[5] Pinderjit Singh., Rajnish Kumar., and Harinder Singh., Estimation of Sertraline Hydrochloride from tablet
formulation, Int. J. of Pharma. Research & Development.,2011,Vol-3(I),016; 175-179.
[6] I Singhvi, and S.C. Chaturvedi., Estimation of Sertraline Hydrochloride from tablet formulation, Indian. J. of
Pharm. Sciences.,2000, vol-62 (6); 468-470.

4. Ravindra N, et al / Int. J. of Pharmacy and Analytical Research Vol-3(4) 2014 [422-425]
www.ijpar.com
~ 425~
[7] Sanjay Bais, Manank Bhausar and I Singhvi., Estimation of Sertraline Hydrochloride and Alprazolam by
HPLC in tablet formulation, The Pharma Research ., 2014-11(1); 6-16.
[8] B.Gopi Krishna, A Maruthi and S. Muneer., Determination of Sertraline Hydrochloride in bulk and tablets by
UV Spectrometric method, Int. J. of Medicine and Research.,2014, vol 2(4); 675-679.
[9] Indian pharmacopoeia ,4th
Edn., Vol II, A-144.
*******************